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CTRI Number  CTRI/2023/05/052307 [Registered on: 04/05/2023] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of dexamethasone in nebulized versus intravenous route in prevention of post operative sore throat 
Scientific Title of Study   Nebulized Dexamethasone versus intravenous Dexamethasone in prevention of post operative sore throat in patient undergoing endotracheal intubation during general anesthesia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Debahuti Chatterjee 
Designation  Junior Resident  
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anesthesiology, Kasturba Medical college Manipal, Tiger circle road, Madhavnagar, Manipal , Karnataka

Udupi
KARNATAKA
576104
India 
Phone  7063279142  
Fax    
Email  chatterjeedebahuti@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Laxmi Shenoy 
Designation  Associate professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anesthesiology Kasturba Medical college Manipal, tiger circle road Madhav Nagar , Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8073822017  
Fax    
Email  drlaxmishenoy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta Sinha 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of Anesthesiology Kasturba Medical college Manipal, tiger circle road Madhav Nagar , Karnataka

Udupi
KARNATAKA
576104
India 
Phone  8879056117  
Fax    
Email  shweta1987.SS95@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College , Manipal 
 
Primary Sponsor  
Name  Kasturba Medical Colleges 
Address  Kasturba Medical college, Manipal Karnataka Pin 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Debahuti Chatterjee   Kasturba Medical College Manipal  Department of Anesthesiology, Main OT complex, Balia’s block, Kasturba Medical college & hospital , Udipi Karnataka 576104 Tiger circle road ,Manipal, Karnataka
Udupi
KARNATAKA 
7063279142

chatterjeedebahuti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group   Patient will not be given intravenous or nebulized Dexamethasone  
Intervention  group intravenous   single dose of intravenous dexamethasone 0.2mg/kg half an prior to induction with general anesthesia 
Comparator Agent  group nebulized   single dose of nebulized dexamethasone 0.2mg/kg prior to induction with general anesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  •Adult patient aged 18-60 years of either gender
•ASA PS grade I/ II scheduled to undergo surgery requiring general anesthesia with duration less than 3hrs
 
 
ExclusionCriteria 
Details  1. Patient with anticipated difficult airway
2. Patient on steroids
3. Patient on recent history URTI/ LRTI
3.patient requiring more than 2 attempts during intubation
4.patients with history of diabetes mellitus
5. Head neck surgeries
6 Patient in whom Dexamethasone is from surgical side contraindicated  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of post operative sore throat .  Presence of sore throat and grading will be done at 12 hrs , 24 hrs and 48 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
1. To note the presence of cough and hoarseness of voice 2. Pre and post operative blood sugar levels

 
Presence of sore throat and grading will be done at 12 hrs , 24 hrs and 48 hrs 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="138" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   11/05/2023 
Date of Study Completion (India) 12/07/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   not published in any National or international Journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Sore throat is a common postoperative complaint occuring in adults in the post operative period following general anesthesia. Postoperative sore throat can result in cough which can cause strain and increased pain at surgical site . Several pharmacological and non pharmacological methods have been tried to decrease the incidence and severity of post operative sore throat. Dexamethasone is a potent corticosteroid with anti-inflammatory property. In this study we compare the effectiveness of intravenous versus nebulized dexamethasone in preventing post operative sore throat with the least undesirable effects .In this study patients will be assessed a day prior to surgery during the preanesthetic checkup and the patients who will fulfil the inclusion criteria will be included in the study. The randomization will be done by using a computer-generated random number table and the patient will be allocated into one of the three groups. In the first group patient will receive intravenous dexamethasone (0.2mg/kg of body weight) half an hour before induction of anesthesia. The second group will be given nebulization with dexamethasone (0.2mg/kg of body weight with 3ml of NS) half an hour before induction of anesthesia. The third group will be a control group who will not be given either intravenous or nebulized dexamethasone. All patient taken up for surgery will be premedicated as per standard protocol. On the day of the surgery, patient will be taken to pre operative area where noninvasive blood pressure, pulse oximeter would be attached and vitals will be noted. Preoperatively GRBS will also be noted while securing intravenous cannula. Patient will be nebulized with dexamethasone or be given intravenous dexamethasone according to randomization 30 min prior to induction. The patient will be then shifted to operation theatre and standard ASA monitors will be attached. Anesthesia will be induced according to the respective anesthetist discretion.. Airway will be secured with PVC portex tubes of appropriate sizes (size of 7mm and 8mm internal diameter for females and males respectively) . The Cormack- Lehane grade would be noted in all patient during laryngoscopy , patient with grade IIb and above would be excluded. The cuff would be inflated with room air and cuff pressure would be kept at 25 -30 cms of water intraoperatively .The ETT tube placement would be confirmed with the appearance of square wave end tidal capnography. Anesthesia would be maintained with isoflurane (1-1.5%)in oxygen- air mixture. Mechanical ventilation would be adjusted to maintain partial pressure of carbon dioxide between 30- 35mmHg. Cuff pressure would be monitored with cuff manometer every 30 min and would be maintained at 25 –30 cms of water. Paracetamol infusion of 15mg/kg and fentanyl boluses will be administered for intraoperative pain. For post-operative pain all patients will receive paracetamol infusion of 15mg/kg 8th hourly. At the end of the surgery, gentle oral suctioning would be done and anesthesia would be reversed with glycopyrrolate 0.01mg/kg and neostigmine 0.05mg/kg. Any cough/ blood over the ET tube during extubation will be noted. Pre extubation GRBS will be noted to rule out any systemic absorption causing increase in blood sugars. 
 
 
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